CART-19 Cells For Patients With Minimal Residual Disease (MRD) Positive CD19+ Acute Lymphoblastic Leukemia
| Registry | NCT03027739, acronym CCFMPCA |
|---|---|
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | Fujian Medical University (Other) |
| Conditions | Acute Lymphoblastic Leukemia |
| Interventions | CART-19 (Biological) |
| Dates | start 2016-11-01, primary completion 2019-12-01 (estimated), completion 2020-12-01 (estimated), first posted 2017-01-23, last updated 2017-01-23 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Lymphoblastic Leukemia All trials of CART-19
CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of relapse as defined by MRD+ status.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1 | Experimental | Biological: CART-19 | CART-19 cells treated |
Sex: All, ages: 1 Year to 60 Years
Inclusion Criteria: * Signed written informed consent * Aged between 1-60 years * Patients with MRD positive CD19+ ALL * Cardiac: Left ventricular ejection fraction ≥ 50% * Adequate renal and hepatic function * Performance status: Karnofsky ≥ 70% Exclusion Criteria: * Pregnant or lactating females. * Any co-morbidity precluding the administration of CART-19 cells.
| Facility | City | Country | Status |
|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou, Fujian | China | Recruiting |